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. 2021 May 30;6(8):2159-2170.
doi: 10.1016/j.ekir.2021.05.034. eCollection 2021 Aug.

Randomized Trial-PrEscription of intraDialytic exercise to improve quAlity of Life in Patients Receiving Hemodialysis

Sharlene A Greenwood  1   2 , Pelagia Koufaki  3 , Jamie H Macdonald  4 , Sunil Bhandari  5 , James O Burton  6 , Indranil Dasgupta  7 , Kenneth Farrington  8 , Ian Ford  9 , Philip A Kalra  10 , Sharon Kean  9 , Mick Kumwenda  11 , Iain C Macdougall  1   2 , Claudia-Martina Messow  9 , Sandip Mitra  12 , Chante Reid  1 , Alice C Smith  13 , Maarten W Taal  14 , Peter C Thomson  15 , David C Wheeler  16   17 , Claire White  1 , Magdi Yaqoob  18 , Thomas H Mercer  3
Affiliations

Randomized Trial-PrEscription of intraDialytic exercise to improve quAlity of Life in Patients Receiving Hemodialysis

Sharlene A Greenwood et al. Kidney Int Rep. .

Abstract

Introduction: Whether clinically implementable exercise interventions in people receiving hemodialysis (HD) therapy improve health-related quality of life (HRQoL) remains unknown. The PrEscription of intraDialytic exercise to improve quAlity of Life (PEDAL) study evaluated the clinical benefit and cost-effectiveness of a 6-month intradialytic exercise program.

Methods: In a multicenter, single-blinded, randomized, controlled trial, people receiving HD were randomly assigned to (i) intradialytic exercise training (exercise intervention group [EX]) and (ii) usual care (control group [CON]). Primary outcome was change in Kidney Disease Quality of Life Short-Form Physical Component Summary (KDQOL-SF 1.3 PCS) from baseline to 6 months. Cost-effectiveness was determined using health economic analysis; physiological impairment was evaluated by peak oxygen uptake; and harms were recorded.

Results: We randomized 379 participants; 335 and 243 patients (EX n = 127; CON n = 116) completed baseline and 6-month assessments, respectively. Mean difference in change PCS from baseline to 6 months between EX and CON was 2.4 (95% confidence interval [CI]: -0.1 to 4.8) arbitrary units (P = 0.055); no improvements were observed in peak oxygen uptake or secondary outcome measures. Participants in the intervention group had poor compliance (47%) and poor adherence (18%) to the exercise prescription. Cost of delivering intervention ranged from US$598 to US$1092 per participant per year. The number of participants with harms was similar between EX (n = 69) and CON (n = 56). A primary limitation was the lack of an attention CON. Many patients also withdrew from the study or were too unwell to complete all physiological outcome assessments.

Conclusions: A 6-month intradialytic aerobic exercise program was not clinically beneficial in improving HRQoL as delivered to this cohort of deconditioned patients on HD.

Keywords: chronic kidney disease; physical activity; physical function; rehabilitation.

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Figures

None
Graphical abstract
Figure 1
Figure 1
CONSORT diagram of the flow of patients across the various phases of the trial. CONSORT, Consolidated Standards of Reporting Trials; PD, progression disease.
Figure 2
Figure 2
Cost-effectiveness: estimated differences in cost and QALYs on the ICER plane for a low staff-to-patient ratio, outside London (5000 bootstrap samples). ICER, incremental cost effectiveness ratio; QALY, quality-adjusted life year.
Figure 3
Figure 3
Number (%) of recorded incidents of temporary cessation (>2 weeks) or missed exercise sessions with reasons.
See this image and copyright information in PMC

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